NCT05906290

Brief Summary

This study develops a multigenerational electronic Health (eHealth) (web and mobile phone-based) program to improve physical activity levels and to better understand the relationship between grandparents and their grandchildren. The importance of social and familial support for older adults and the need to address increasing declines in physical activity for both children and older adults. Health promotion interventions that capitalize on the existing relationship between grandparents and grandchildren may simultaneously improve health-related outcomes for older adults and children.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2018

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

June 6, 2023

Last Update Submit

June 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Program acceptability as measured by Qualitative Interview Guide Field Trial

    Program acceptability will be measured by Qualitative Interview Guide Field Trial. Participants indicate whether they like the program in a qualitative exit interview. The interview guide consists of 13 open-ended questions regarding the participant's experience testing the program. Acceptability will be based on emergent themes.

    2 weeks

Study Arms (1)

Multigenerational eHealth Intervention for Grandparents and Grandchildren Group

EXPERIMENTAL

Participants in this group will have access to eHealth intervention for 2 weeks.

Other: Multigenerational eHealth Intervention for Grandparents and Grandchildren

Interventions

Participants in this group will use an online program for 30-45 minutes per week over the course of 2 weeks delivered via smartphone, focusing on increasing physical activity.

Multigenerational eHealth Intervention for Grandparents and Grandchildren Group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female or male grandparent with a grandchild
  • Grandparent is at least 45 years old
  • Grandparent has a grandchild between the ages of 6-12 years old
  • Grandparent is English or Spanish speaking

You may not qualify if:

  • Grandparent has a chronic medical condition that interferes with physical activity (e.g., wheelchair bound, severe heart disease, uncontrolled hypertension, brittle diabetes mellitus, chronic arthritis)
  • Grandparent has a diagnosis of dementia or significant cognitive impairment based on the telephone interview for cognitive status (TICS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kobayashi MA, St George SM, Leite RO, Noriega Esquives B, Wetstone R, Pulgaron ER, Prado G, Czaja SJ. Formative Development of a Technology-Based Physical Activity Intervention for Grandparents and Grandchildren. J Aging Phys Act. 2022 Jun 1;30(3):482-494. doi: 10.1123/japa.2020-0481. Epub 2021 Oct 5.

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sara M St. George, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

May 16, 2018

Primary Completion

February 5, 2019

Study Completion

December 18, 2020

Last Updated

June 15, 2023

Record last verified: 2023-06